Improving the Regulatory Review Process: Assessing Performance and Setting Targets

Edited By McAuslane,Neil and Walker,Stuart

ISBN 10: 0792387317 / ISBN 13: 9780792387312

Published by Kluwer Academic Publishers, 1998

About this Item

Type: Book At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as "what target should be set for the review of new medicines?" and "how can quality be assured?" are now considered to be of critical importance. The 12th CMR International Workshop, held in January 1997, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarizes the many suggestions that were debated at the workshop, and includes chapters on measuring performance, and on the integration of quality into the review process. 163pp.

Seller Inventory # 015178

Bibliographic Details

• Title: Improving the Regulatory Review Process: Assessing Performance and Setting Targets
• Publisher: Kluwer Academic Publishers
• Publication Date: 1998
• Language: English
• ISBN 10: 0792387317
• ISBN 13: 9780792387312
• Binding: Cloth/Laminated Boards
• Condition: Very Good
• Dust Jacket Condition: No d/j as Published
• Weight: 14 ounces
• Seller catalogs:
  • MEDICINE

About this title

Synopsis

At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance.
The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.